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临床试验/CTRI/2020/03/023705
CTRI/2020/03/023705尚未招募4 期

A Single Arm Clinical Study To Evaluate The Efficacy Of Madhuyastikalp (Titrated Dose)And Rasayan Chikitsa In The Management Of Bronchiectasis Vis-A-Vis Kshataksheena

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Changes in sign and symptoms of Bronchiectesis (Kshataksheen)

研究概览

简要总结

Bronchiectasis is characterised by permanent and abnormal dilatation of the lung airways (bronchi). It arises from  persistent bacterial airway infection on a background of a deficient immune response .the classical presenting complaints in patients of post tubercular bronchiectasis  are cough with copious sputum –mucoid,  mucopurulent or purulent. dyspnea, haemoptysis is, chest pain and fever may be present  in varying proportions.

Bronchiectasis is seen in 30–60% of patients with active postprimary form TB and in 71–86% of patients with inactive disease. In Ayurveda, signs and symptoms of Urakshata are very similar to bronchiectasis of modern medicine.

The cardinal features  are (cough) kasa with yellowish-black, foul smelling sputum and (haemoptysis) shonitachhardi. Ayurveda also considers interrelation-ship between bronchiactasis (Urakshata) and tuberculosis (Rajyakshma).

According to Charaka, Urakshta if not treated appropriately, may further lead to Rajyakshma.

In Ayurveda jivantyadi ghrita has good efficacy in reducing productive cough, haemoptysis, dyspnea and thus it is in bronchiectasis.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients having classical sign and symptoms of Kshataksheen 2.The study will include individuals with known diagnosis of Bronchiectasis by high resolution computed tomography (HRCT) scan 3.Clinically being stable minimum from one month 4.Not under going excercise training programme or nay other lung rehabilitation therapy 5.No acute exacerbation of Bronchiectasis.

排除标准

  • 1.Severe obstructive airway disease (FEV1 <50%, FEV1/FVC<70%) 2.Patients who are unable or unwilling to provide informed consent 3.Diagnosis of other active lung diseases (i.e. ABPA, active tuberculosis) 4.Patient taking steroid therapy from long duration (systemic or inhaled) 5.Past or current malignancy within 5 years 6.Pregnant ladies and lactating mothers 7.History of any adverse drug reaction 8.Patients having positive HIV1 and 2 or positive Hepatitis B 9.Patients with severe cardiovascular disease 10.Patients with poorly controlled Hypertension (>160/100mmhg) 11.Patients with cystic fibrosis or history of cystic fibrosis 12.Patients having Diabetes Mellitus.

结局指标

主要结局

Changes in sign and symptoms of Bronchiectesis (Kshataksheen)

时间窗: 105 days

次要结局

  • 1.Chnages in MRC dyspnoea scale(2.Changes in HRCT scan)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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